Hospital-error oversight called lax

State takes too long to investigate mistakes, patient advocates say

By ANGELA GALLOWAY, SEATTLE POST-INTELLIGENCER REPORTER

Published 10:00 pm, Wednesday, May 4, 2005

When a Washington hospital amputates the wrong leg, makes a fatal medication error or discovers any such mistake has seriously hurt a patient, state law demands that the facility notify regulators within two days. The state Health Department even provides a toll-free hot line.

Next, a high-level bureaucrat logs the date, type and location of the "adverse event" into a computer spreadsheet only he can access.

That's where the urgency ends. The state is required to investigate, but there's no time frame for doing so. The report sometimes sits idle in the computer's memory for years.

Related Stories

It may surprise patients to hear that a major health care mistake does not immediately trigger an independent investigation -- or even a phone call from the state. In fact, most states don't even require hospitals to report such errors.

And although slim resources delay follow-up by Washington regulators on such incidents, the system is passive by design. In general, hospitals are expected to be their own primary investigators.

That has some patient advocates calling for fundamental changes, here and nationwide.

Washington may soon join a handful of states on the front line of a policy reform movement -- one that has regulators straining to balance the public's expectation that they will hold hospitals accountable with a desire for a less punitive relationship that encourages honesty.

"What we are doing is trying to figure out what is government's role," said Laurie Jinkins, the state health department's head of health systems quality assurance. "There's not a lot of really good data out there so it is really kind of a struggle."

How it works

Under a state law only 6 years old, once a hospital confirms that an "adverse event" has occurred, it has two days to report it to the state. But the hospital can take as long as it wants to confirm the event.

The hospital only has to report the date and category of an event: unanticipated patient death or "major permanent losses of function"; transfusion with the wrong blood type; surgery on the wrong patient or body part; patient suicides; infant abduction; sexual assault; fire; and major facility system malfunction.

At least 340 such events have been reported since 1999. About half of them involved deaths or disability, said Byron Plan, executive manager of the state health department's Office of Health Care Survey.

But the state does not investigate such reports until the hospital is due for its next routine licensing inspection -- unless someone files a complaint or the news media reports an incident.

For example, an investigation was ordered last month after the Seattle Post-Intelligencer published articles about a Virginia Mason Medical Center patient who was accidentally set on fire during a surgical procedure in 2003. In that case, no violations of hospital licensing rules were found, the health department said earlier this week.

In general, regulators chose a wait-and-see approach because they wanted to evaluate the event within the context of the hospital's own internal review, Plan said. "It is questionable if we add anything by going in and looking at how they're investigating it when they're investigating it," he said.

Until recently, Washington law required annual hospital inspections. But because of limited staffing, that threshold hasn't been met for at least two decades, Plan said. The average wait time was 20 to 21 months, he said, and sometimes it took several years.

The Legislature recently pushed the inspection cycle back to every 18 months and added one staffer. Plan thinks the department can meet the new 18-month threshold.

Yet another complication can come into play: Most hospitals can request that every other inspection be conducted by a private national group called the Joint Commission on Accreditation of Healthcare Organizations. The details of the findings of such inspections are not available to the public unless the hospital releases them.

The state does review the JCAHO findings, and can sanction a hospital if regulators think the response was inadequate. Most often, the state requires the hospital to submit a plan of corrections. Sometimes the state imposes its own plan.

State regulators also have the authority to restrict, suspend or revoke a hospital's license. A license has been restricted only once in at least a decade, Plan said. In May 2003, regulators suspended a Quincy hospital's ability to accept new patients or provide emergency treatment for about a week after health department inspectors found problems with infection control, medication errors and nursing care plans.

A national dilemma

"They've been there a long time and are probably very spottily carried out because there's not amechanism for enforcement," said Kala Ladenheim, a health policy analyst for the National Conference of State Legislatures. Fewer than half of the states even require hospitals to report "adverse events" that severely injure or kill patients, Ladenheim said.

It's long been the exclusive task of private medical organizations to review their errors. In recent years, the public and politicians have become increasingly leery about relying on such self-examination, and have pushed for a more open and independent quality assurance model.

Still, changes must be weighed against the need to keep from turning the system too punitive, said Jinkins of the health department. "There's a fair amount of data out there that says creating more of a blame-free environment actually creates patient safety better than almost anything else," she said.

However, some watchdogs say it's time for radical change. Certain mistakes demand assertive independent oversight to prevent systemic problems in hospitals, such as poor medication management, from leading to repeated errors, Wolfe said.

"I mean, it's just common sense," Wolfe said.

Changes coming

As in other states, regulators here say they want policy changes to improve patient safety while maintaining a cooperative -- not punitive -- relationship with hospitals.

By next summer, the health department hopes to change mistake-reporting rules. The state would like to require hospitals to report "adverse events" within 45 days of the incident, rather than giving them unlimited time to confirm such events. And the state plans to adopt reporting guidelines developed by the non-profit National Quality Forum.

Those more specific standards would clarify for hospitals what they're supposed to report, from a serious overdose to a mother's death during a low-risk delivery. They also would allow the department to gather trend data on mistakes so regulators could share that data with the public and the health care industry in an effort to prevent such errors, Plan said.

Minnesota adopted such standards two years ago. Earlier this year, health officials there released data on 99 adverse events, which resulted in 20 deaths.

The most common mistake involved leaving behind a foreign object, such as a sponge, inside a patient during surgery.

Philip Dunn, spokesman for the National Quality Forum, said Washington would be the fourth state to adopt such standards for identifying and tracking "events that should never occur in any clinical care setting but unfortunately do."